Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT05847205
Status:
UNKNOWN
Last Update Posted:
2023-05-06
First Post:
2023-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluation of Recombinant Hirudin in Prophylaxis of Post-Operative Deep Vein Thrombosis
Sponsor:
MinaPharm Pharmaceuticals
Organization:
Study Overview
Official Title:
A Prospective, Single- Center, Phase IV, Interventional, Single Arm Trial for the Evaluation of Subcutaneous Recombinant Hirudin 15 mg (RB Variant) in Prophylaxis of Deep Vein Thrombosis (DVT) Post Major Orthopedic Operations
Status:
UNKNOWN
Status Verified Date:
2023-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Thromb-001
Brief Summary:
This study aims to evaluate the efficacy and safety of r-Hirudin RB variant 15 mg in DVT prophylaxis post major orthopedic operations
Detailed Description:
Prospective, Single arm, single-center
Phase IV
100 Patients will be treated with r-Hirudin (Thrombexx) for a total of 15 days beginning with 15 mg BID s.c starting 6 hours after surgery or upon adequate hemostasis and continued until end of study.
Patients undergoing major orthopedic operations
For Events of Deep Vein Thrombosis (DVT) within 15 days post-op.) All of the patients underwent Routine bilateral compression Doppler.
For Clinical PE (Pulmonary Embolism) Events from Day of surgery and During Hospitalization period or end of study
Clinical PE events PE (Pulmonary Embolism) events were confirmed by spiral CT.
For follow up:
APTT should be done before the first dose then after 4 \& 8 hours of the first dose, then on days 1,8,15 post operatively.
Enrolment period: 3 months duration Follow-up duration: Follow-up per patient will be for a period of 15 days
Primary endpoint:
• Primary end points included new onset symptomatic thrombosis requiring medical or surgical intervention or death due to thrombosis defined as fatal PE, ischemic stroke, mesenteric thrombosis, or myocardial infarction
Secondary endpoint:
* The Secondary end point of major bleeding is defined as clinically evident hemorrhage associated with a hemoglobin decrease ≥ 2 g/dL that leads to a transfusion of ≥2 units of whole blood or packed red cells outside of the perioperative period (time from the start of the surgery or procedure and up to 12 hours after), or hemorrhage that is intracranial, retroperitoneal, or into a prosthetic joint.
* Recording serious adverse events (SAE)/ adverse events (AE) during the study duration.
Phase IV
100 Patients will be treated with r-Hirudin (Thrombexx) for a total of 15 days beginning with 15 mg BID s.c starting 6 hours after surgery or upon adequate hemostasis and continued until end of study.
Patients undergoing major orthopedic operations
For Events of Deep Vein Thrombosis (DVT) within 15 days post-op.) All of the patients underwent Routine bilateral compression Doppler.
For Clinical PE (Pulmonary Embolism) Events from Day of surgery and During Hospitalization period or end of study
Clinical PE events PE (Pulmonary Embolism) events were confirmed by spiral CT.
For follow up:
APTT should be done before the first dose then after 4 \& 8 hours of the first dose, then on days 1,8,15 post operatively.
Enrolment period: 3 months duration Follow-up duration: Follow-up per patient will be for a period of 15 days
Primary endpoint:
• Primary end points included new onset symptomatic thrombosis requiring medical or surgical intervention or death due to thrombosis defined as fatal PE, ischemic stroke, mesenteric thrombosis, or myocardial infarction
Secondary endpoint:
* The Secondary end point of major bleeding is defined as clinically evident hemorrhage associated with a hemoglobin decrease ≥ 2 g/dL that leads to a transfusion of ≥2 units of whole blood or packed red cells outside of the perioperative period (time from the start of the surgery or procedure and up to 12 hours after), or hemorrhage that is intracranial, retroperitoneal, or into a prosthetic joint.
* Recording serious adverse events (SAE)/ adverse events (AE) during the study duration.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: